A Study of Aminolevulinic Acid Used to Enhance Visualization and Surgical Removal of Brain Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01351519
Recruitment Status : Terminated (Limited staff available for enrollment and limited availability of drug)
First Posted : May 11, 2011
Last Update Posted : March 17, 2016
Information provided by (Responsible Party):
MultiCare Health System Research Institute

Brief Summary:
In this study subjects will be administered a single oral dose of Aminolevulinic Acid (ALA) prior to surgical resection of their brain tumor. The ALA ultimately causes brain tumor tissue to fluoresce or light up under ultraviolet light. During surgery an ultraviolet light in the microscope chain will be turned on. The tumor tissue will fluoresce bright pink allowing the surgeon to more easily differentiate tumor tissue from normal brain tissue. The aim of the study is to determine whether ALA and fluorescent visualization of tumor tissue improves the surgeon's ability to completely resect or remove the brain tumor.

Condition or disease Intervention/treatment Phase
Malignant Glioma Glioma Glioblastoma Glioblastoma Multiforme Astrocytoma Drug: Aminolevulinic Acid Phase 2

Detailed Description:
This is a Phase 2 study and all subjects will receive open label Aminolevulinic Acid in a dose of 20mg/kg given orally 3 hours prior to surgery. Brain tumors will be resected with the aid of ultraviolet light to visualize the tumor. After surgery an MRI will be done to determine whether the tumor has been completely or partially resected. All subjects will be followed for safety. All subjects will be followed closely by clinical examination and by MRI to monitor for disease recurrence.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Study of Aminolevulinic Acid (ALA) to Enhance Visualization and Resection of Malignant Glial Tumors of the Brain
Study Start Date : May 2011
Actual Primary Completion Date : January 2015
Actual Study Completion Date : January 2015

Arm Intervention/treatment
Experimental: Aminolevulinic Acid (AL) Drug: Aminolevulinic Acid
Aminolevulinic Acid will be administered as a single oral dose of 20mg/kg given in 50ml of water three hours before surgery.
Other Names:
  • ALA
  • 5-Aminolevulinic Acid
  • Levulan

Primary Outcome Measures :
  1. Time to disease progression after initial surgery. [ Time Frame: Up to 2 years ]
    Determine time-to-progression compared to that in comparable cases performed without the aid of ALA.

  2. Complete Resection [ Time Frame: Day 2 ]
    Determine the percentage of patients with complete resections of contrast-enhancing tumor, compared to historical controls

Secondary Outcome Measures :
  1. Determine the number of subjects with adverse events due to ALA in this dosage and indication. [ Time Frame: Through 45 days ]
    Subjects will be followed closely for adverse events including biochemical abnormalities through laboratory monitoring and for clinically evident adverse events including possible skin reactions that may occur.

  2. Overall Survival [ Time Frame: Up to three years ]
    Determine the overall survival compared to historical controls.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Clinically documented primary brain tumor for which surgical resection is indicated.
  • Age 18 years and older.
  • ECOG Performance status less than or equal to 2.
  • Laboratory values as follows:

Leukocytes greater than or equal to 3,000. ANC greater than or equal to 1,500. Platelets greater than or equal to 100,000. Total Bilirubin WNL. AST/ALT less than or equal to 2.5 times ULN. Creatinine WNL. or Creatinine Clearance greater than or equal to 60ml/min/1.73m2 if SCr above institutional normal.

-Ability to provide informed consent or consent from a Legally Authorized Representative.

Exclusion Criteria:

  • Receipt of an investigational agent within 30 days.
  • Allergy to ALA or similar compounds.
  • Personal or family history of porphyria.
  • Uncontrolled intercurrent illness.
  • Inability to comply with the protocol.
  • Pregnancy, breastfeeding.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01351519

United States, Washington
MultiCare Health System Research Institute
Tacoma, Washington, United States, 98405
Sponsors and Collaborators
MultiCare Health System Research Institute
Principal Investigator: William Morris, MD MultiCare Health System
Study Director: Richard Shine, PharmD, BCPS MultiCare Health System Research Institute

Publications of Results:
Responsible Party: MultiCare Health System Research Institute Identifier: NCT01351519     History of Changes
Other Study ID Numbers: ALA 11.07
First Posted: May 11, 2011    Key Record Dates
Last Update Posted: March 17, 2016
Last Verified: March 2016

Keywords provided by MultiCare Health System Research Institute:
Glioblastoma Multiforme
Brain Tumor

Additional relevant MeSH terms:
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Aminolevulinic Acid
Photosensitizing Agents
Dermatologic Agents